Not Yet RecruitingPhase 2

A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer

30 participantsStarted 2024-04-02

Plain-language summary

This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female, age≥ 18 years；
✓. Patients with a diagnosis of gastric cancer by histopathology or cytology, accompanied by peritoneal metastasis, without systemic therapy, or for patients who have received neoadjuvant/adjuvant chemotherapy before, the time from last treatment to disease recurrence \> 6 months;
✓. Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-).
✓. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors （RECIST) 1.1;
✓. WBC≥3.0×10\^9 /L; ANC≥1.5×10\^9 /L; HB≥90 g/L; PLT≥75×10\^9 /L;
✓. ALT and AST≤3×ULN (≤5×ULN with liver metastasis); ALB≥20g/L; Cr≤1.5×ULN or CCr\>50 mL/min; TBIL≤1.5×ULN; APTT≤1.5×ULN and INR or PT≤1.5×ULN (without anticoagulation therapy)
✓. LVEF≥50%; male QTc≤450 mms, female QTc≤470 mms;
✓. ECOG 0\~1；

Exclusion criteria

✕. History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration;
✕. Patients with central nervous system metastases with clinical symptoms;
✕. Patients who have been treated with high-dose systemic corticosteroids (prednisone \> 10 mg/day or equivalent doses) or other immunosuppressants within 2 weeks before the first dose of BioTTT001;
✕. Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001;
✕. Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 14 days before the first dose of BioTTT001;
✕. Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia );
✕. Patients with primary immunodeficiency;
✕. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia);

What they're measuring

Objective response rate (ORR)

Timeframe: Imaging was performed every 6 weeks during the combination therapy phase

Trial details

NCT IDNCT06283121

SponsorChina Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-30

Contact for this trial

Shuhui Song, bachelor

15004240769 593900927@qq.com

View on ClinicalTrials.gov More Gastric Cancer, Metastatic trials